Alimera Sciences Signs Agreement To Distribute ILUVIEN® In The Middle EastDecember 15, 2015
ATLANTA, Dec. 15, 2015 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that its subsidiary, Alimera Sciences B.V., has signed an agreement with MEAgate International FZLLC (MEAgate), headquartered in the United Arab Emirates (UAE), to distribute ILUVIEN® throughout much of the Middle East. The countries included in the agreement are Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, UAE, and Yemen, where an estimated 16 million people today are living with diabetes.
MEAgate is led by a seasoned management team with more than 35 years of pharmaceutical and medical device experience in the Middle East including tenure with Merck, Medtronic and GE Healthcare. In addition to the management team's experience, the board of directors is comprised of individuals with extensive pharmaceutical distribution experience throughout the Middle East.
Under the terms of the agreement, MEAgate will open a scientific office for Alimera in the Middle East to support regulatory, medical affairs, and sales and marketing operations. In addition to its administrative and regulatory support personnel, MEAgate will initially have a team of five Medical Science Liaisons, with two in Saudi Arabia, two in Egypt and one in the Gulf Cooperation Council countries, to support Named Patient Sales, which are expected to begin in Saudi Arabia, Egypt, UAE and Lebanon in 2016. Named Patient Sales is an early access program where health authorities allow selected institutions to provide globally approved innovative medications to their patients while the products are still in the process of approval and full registration. MEAgate will assist Alimera in registering ILUVIEN in all countries included in the agreement.
"The Middle East market holds great opportunity with a population that exceeds 200 million people, a high rate of diabetes and developing healthcare systems," said Dream Samir, Partner and CEO of MEAgate. "We believe ILUVIEN will be a welcome addition for those with diabetic macular edema in the region. MEAgate will ensure high scientific and compliant standards while managing a network of carefully chosen country distributors for Alimera."
"MEAgate is an excellent partner for Alimera to increase the availability of ILUVIEN," said Dan Myers, president and CEO, Alimera. "Their management team knows how to navigate the variable economic and healthcare systems across countries in the region, which should provide us with a terrific opportunity to make ILUVIEN a market leader in the Middle East."
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the U.S. to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Each ILUVIEN implant is designed to release submicrogram levels of fluocinolone acetonide (FAc), a corticosteroid, for 36 months.
Corticosteroids have a history of effective use in treating ocular disease inflammation. ILUVIEN is injected in the back of the patient's eye with an applicator that employs a 25-gauge needle, which allows for a self-sealing wound. In the FAME™ Study, a phase 3 clinical study of ILUVIEN, the primary endpoint of improvement in vision of 15 letters or more was demonstrated at 24 months and the most frequently reported adverse drug reactions included cataract development and increased ocular pressure.
About Diabetic Macular Edema (DME)
DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. According to the International Diabetes Foundation's Diabetes Atlas Sixth Edition, Update 2014, the comparative prevalence of diabetes in the countries covered by the agreement with MEAgate ranges from 8% to 24% of the population.
About MEAgate International FZ LCC
The management team of MEAgate are seasoned pharmaceutical and life sciences executives with over 35 years combined experience in selling pharmaceuticals and medical devices in much of the Middle East. They have developed a Middle East hub to address the needs of small to medium innovative companies, and become the partner of choice that ensures highest scientific and compliant standards while managing - on behalf of the company - a network of carefully chosen country distributors. Teams are centrally selected, hired and trained, ensuring that the same high standards are applied across the region.
About Alimera Sciences, Inc.
Alimera Sciences, Inc., headquartered in Alpharetta, Georgia, is a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera's European operations are conducted by its subsidiary, Alimera Sciences Limited, based in the United Kingdom.